About

Avalyn is developing inhaled therapies for people with severe and rare respiratory diseases.

Avalyn is a clinical-stage biopharmaceutical company developing inhaled medicines to treat rare respiratory diseases, including Idiopathic Pulmonary Fibrosis (IPF) and other Interstitial Lung Diseases (ILD). ILDs are characterized by pulmonary scarring, a decline in lung function, reduced exercise capacity and quality of life, and increased mortality risk. Currently approved therapeutic options slow disease progression but are associated with significant side effects, which restrict their use and dosing. Avalyn is developing a pipeline of inhaled medicines to reduce systemic exposure and deliver the medication directly to the disease site. AP01, Avalyn’s lead candidate, is a Phase 2b-ready inhaled formulation of pirfenidone optimized for direct lung delivery via inhalation. In a recent clinical study of two doses assessed in 91 individuals with IPF, AP01 demonstrated the potential to improve efficacy and safety over existing therapy.

Learn more about this approach and our therapeutic focus.

Lyn Baranowski photo

Lyn Baranowski

Chief Executive Officer

Mark Surber, Ph.D. photo

Mark Surber, Ph.D.

Founder and Chief Scientific Officer

Marc Schneebaum photo

Marc Schneebaum

Chief Financial Officer

Nancy McKinley photo

Nancy McKinley

Senior Vice President, Administration & Finance

Michelle Patterson photo

Michelle Patterson

Senior Vice President, Program Management

Stephen Pham, Ph.D. photo

Stephen Pham, Ph.D.

Senior Vice President, Product Development

Felix Woodhead, M.D., Ph.D. photo

Felix Woodhead, M.D., Ph.D.

Senior Medical Director

Niall O’Donnell, Ph.D. photo

Niall O’Donnell, Ph.D.

Chairman, Managing Director, RiverVest Venture Partners

Lyn Baranowski photo

Lyn Baranowski

Chief Executive Officer

Tiba Aynechi photo

Tiba Aynechi

General Partner, Norwest Venture Partners

Sofia Ioannidou, Ph.D. photo

Sofia Ioannidou, Ph.D.

Director (Life Sciences), Andera Partners

Jonathan Leff, M.D. photo

Jonathan Leff, M.D.

Independent Director

David Malek photo

David Malek

General Partner, Pivotal bioVenture Partners

Peter Moldt, Ph.D. photo

Peter Moldt, Ph.D.

Partner, Novo Ventures (US), Inc.

Ketan Patel, M.D. photo

Ketan Patel, M.D.

Partner, F-Prime Capital

Andera Partners Investor LogoF/Prime Investor LogoNorwest Investor LogoNovo Investor Logo

Pivotal Bioventure Partners Investor LogoRivervest Investor LogoTPG Investor Logo

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2010

With family history of IPF, Founder Mark Surber conceives of inhaled pirfenidone (AP01)

2011

First AP01 Patent Filed &

Avalyn Incorporated

2014

First AP01 Publication

AP01 US Orphan Drug Designation for the treatment of IPF

2017

$62M Series A Complete

2018

AP01 Phase 1a Complete

2020

First Inhaled Nintedanib (AP02) Publication

$35M Series B Complete

2022

AP01 Phase 1b POC Complete

AP02 Phase 1a Complete

AP01 EU Orphan Drug Designation for the treatment of IPF

2023

AP01 Phase 2b Design & Series C Fund Raising